Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, the Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial

Newby, D.E. et al. (2012) Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, the Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial. Trials, 13(184), (doi: 10.1186/1745-6215-13-184)

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Abstract

<p>Background: Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic.</p> <p>Methods/design: The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014.</p> <p>Discussion: This is the first study to look at the implementation of computed tomography in the patient care pathway that is outcome focused. This study will have major implications for the management of patients with cardiovascular disease.</p>

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMillan, Dr Nigel and Lanaghan, Mrs Kirsten and Tzemos, Dr Nikolaos and MacLeod, Mr Martin and Brown, Mrs Ammani and Boylan, Mrs Heather and Berry, Professor Colin and Johnstone, Mrs Janet and Hopkins, Mrs Tracey
Authors: Newby, D.E., Williams, M.C., Flapan, A.D., Forbes, J.F., Hargreaves, A.D., Leslie, S.J., Lewis, S.C., McKillop, G., McLean, S., Reid, J.H., Sprat, J.C., Uren, N.G., van Beek, E.J., Boon, N.A., Clark, L., Craig, P., Flather, M.D., McCormack, C., Roditi, G., Timmis, A.D., Krishan, A., Donaldson, G., Fotheringham, M., Hall, F.J., Neary, P., Cram, L., Perkins, S., Taylor, F., Eteiba, H., Rae, A.P., Robb, K., Barrie, D., Bissett, K., Dawson, A., Dundas, S., Fogarty, Y., Ramkumar, P.G., Houston, G.J., Letham, D., O’Neill, L., Pringle, S.D., Ritchie, V., Sudarshan, T., Weir-McCall, J., Cormack, A., Findlay, I.N., Hood, S., Murphy, C., Peat, E., Allen, B., Baird, A., Bertram, D., Brian, D., Cowan, A., Cruden, N.L., Dweck, M.R., Flint, L., Fyfe, S., Keanie, C., MacGillivray, T.J., Maclachlan, D.S., MacLeod, M., Mirsadraee, S., Morrison, A., Mills, N.L., Minns, F.C., Phillips, A., Queripel, L.J., Weir, N.W., Bett, F., Divers, F., Fairley, K., Jacob, A.J., Keegan, E., White, T., Gemmill, J., Henry, M., McGowan, J., Dinnel, L., Francis, C.M., Sandeman, D., Yerramasu, A., Berry, C., Boylan, H., Brown, A., Duffy, K., Frood, A., Johnstone, J., Lanaghan, K., MacDuff, R., MacLeod, M., McGlynn, D., McMillan, N., Murdoch, L., Noble, C., Paterson, V., Steedman, T., and Tzemos, N.
College/School:College of Medical Veterinary and Life Sciences
College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Trials
Publisher:BioMed Central
ISSN:1745-6215
Copyright Holders:Copyright © 2012 The Authors
First Published:First published in Trials 13:184
Publisher Policy:Reproduced under a Creative Commons License

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